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Clinical Trials (PDQ®)

Phase III Surgery with vs without Adjuvant Chemotherapy with ADR/DTIC/CTX/VCR for Nonmetastatic Soft Tissue Sarcoma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed15 to 70EORTC-62771

Objectives

I.  Study chemotherapy with adriamycin, DTIC, cyclophosphamide, and 
vincristine as an adjunct to surgery in the management of soft tissue sarcoma 
of the extremities and of the head and neck region (and trunk, per January 
1979 revision).
II.  Compare the duration of the disease-free interval and survival in the 
group of patients being treated for 8 months and the patients given no 
chemotherapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 20 to 70 (15 to 70 per 
January 1979 revision) years of age with histologically proven, nonmetastatic 
soft tissue sarcoma that has been totally excised within 13 weeks of study 
entry.  The following histologic types are eligible:  fibrosarcoma, 
liposarcoma, leiomyosarcoma, rhabdomyosarcoma, malignant hemangioendothelioma 
(angiosarcoma), malignant lymphangiopericytoma, malignant 
lymphangioendothelioma (lymphangiosarcoma), malignant synovioma, malignant 
Schwannoma (neurofibrosarcoma), malignant mesenchymoma, alveolar soft-parts 
sarcoma, malignant granular cell tumor, chondrosarcoma of soft parts, 
osteosarcoma of soft parts, malignant giant-cell tumor of soft parts, 
malignant fibroxanthoma, and clear-cell sarcomas of tendons and aponeuroses.  
Patients must have adequate hematological and hepatic function and have had no 
prior preoperative radiotherapy nor chemotherapy nor macroscopic disease after 
tumor excision and no history of other malignant disease except skin cancer.  
Patients with any form of heart disease (excluding asymptomatic minor EKG 
changes) or any serious infection are excluded.  Per January 1979 revision, 
patients with microscopically proven lymph node involvement are ineligible.

Expected Enrollment

An accrual of 210 patients is anticipated.

Outline

Randomized study.  Patients are randomized within 13 weeks of primary surgery 
or of resection of recurrent tumor.
Arm I:  4-Drug Combination Chemotherapy.  Adriamycin, ADR, NSC-123127; DTIC, 
NSC-45388; Cyclophosphamide, CTX, NSC-26271; Vincristine, VCR, NSC-67574.
Arm II:  No Chemotherapy.

Related Publications

Kasper B, Ouali M, van Glabbeke M, et al.: Prognostic factors in adolescents and young adults (AYA) with high risk soft tissue sarcoma (STS) treated by adjuvant chemotherapy: a study based on pooled European Organisation for Research and Treatment of Cancer (EORTC) clinical trials 62771 and 62931. Eur J Cancer 49 (2): 449-56, 2013.[PUBMED Abstract]

Le Cesne A, Van Glabbeke M, Woll PJ, et al.: The end of adjuvant chemotherapy (adCT) era with doxorubicin-based regimen in resected high-grade soft tissue sarcoma (STS): pooled analysis of the two STBSG-EORTC phase III clinical trials. [Abstract] J Clin Oncol 26 (Suppl 15): A-10525, 2008.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Vivien Bramwell, MB, BS, PhD, FRCP, Protocol chair (Contact information may not be current)
Ph: 519-685-8640

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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